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QLT announces 12-month results from Novartis sponsored MONT BLANC study evaluating standard-fluence Visudyne(R) combination therapy
Date:6/15/2009

of patients with a treatment-free interval of at least three months duration after Month 2. There were no unexpected safety findings, and adverse event incidence was similar between treatment groups.

Additional post hoc analysis showed that 85% of patients in the Visudyne combination therapy group, compared with 72% in the Lucentis monotherapy group, had a treatment-free interval of at least four months duration after Month 2. Median time to first retreatment after month 2 was extended by ~1 month in the combination group (month 6) versus the monotherapy group (month 5). Patients in the combination group received, on average, a total of 4.8 ranibizumab injections compared with 5.1 in the monotherapy group and a total of 1.7 Visudyne treatments compared with 1.9 sham treatments in the monotherapy arm. Results are based on ITT analyses (with LOCF); per-protocol analyses yielded similar results. Overall, only 15 patients discontinued the study before Month 12 (6%).

"MONT BLANC provided the first data within the SUMMIT clinical trial program and showed that patients treated with Visudyne combination therapy had non-inferior visual acuity to patients treated with Lucentis monotherapy," said Bob Butchofsky, Chief Executive Officer of QLT Inc. "The results from DENALI, which includes a Visudyne reduced fluence arm, and EVEREST, which studies combination therapy in polypoidal choroidal vasculopathy, may add to the knowledge about the potential benefits of combining Visudyne and Lucentis."

About MONT BLANC Phase II Study

The MONT BLANC study is a Phase II, multicenter, randomized, double-masked study comparing standard-fluence Visudyne-Lucentis combination therapy to Lucentis monotherapy in 255 subjects with choroidal neovascularization (CNV) secondary to wet age-related macular degeneration (wet AMD). Subjects were randomly assigned to one of two treatment groups: Standard-fluence Visudyne (600 mW/cm2 for 83 seconds to deli
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SOURCE QLT Inc.
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